Technical Document Requirements for Class C Medical Device Registration with Vietnam MOH

Class C medical devices in Vietnam must meet the technical documentation requirements outlined in Circular 39/2016/TT-BYT, which aligns with the ASEAN Medical Device Directive (AMDD). Below is a detailed breakdown of the necessary technical documents.

1. Required Technical Documents

A. Device Description & Specifications

✅ Device Name & Model
✅ Intended Use & Indications
✅ Principle of Operation – Explanation of how the device functions.
✅ Material Composition – List of materials used (important for implants and invasive devices).
✅ Comparison with Similar Devices – If applicable, a comparison with other similar medical devices on the market.

B. Risk Classification Justification

✅ Explanation of why the device is classified as Class C based on risk level.
✅ Follows ASEAN AMDD risk classification criteria.

C. Instructions for Use (IFU) & Labeling

✅ User Manual / Instructions for Use (IFU) – Must be in Vietnamese.
✅ Device Labeling & Packaging Information – Must comply with Vietnam MOH regulations, including:

• Product name and model

• Manufacturer and distributor details

• Expiry date (if applicable)

• Warnings and precautions

D. Performance & Safety Testing Reports

✅ Test Reports (if applicable) to verify safety and performance.
✅ Compliance with IEC, ISO, or ASTM standards.
✅ Electrical safety (e.g., IEC 60601 for medical electrical equipment).
✅ Sterilization validation (if applicable).

E. Clinical Evaluation Report (CER)

✅ Required for certain Class C devices.
✅ Can be based on:

• Clinical trials

• Literature review

• Equivalence to an already approved device

F. Declaration of Conformity

✅ A signed and stamped statement from the manufacturer confirming compliance with Vietnam MOH and ASEAN AMDD regulations.

G. Post-Market Surveillance (PMS) Plan

✅ A plan outlining how the manufacturer will monitor and report adverse events, recalls, and safety issues after market approval.

2. Document Format & Submission

📌 All foreign documents must be notarized and legalized (e.g., by an embassy).
📌 Documents must be submitted in PDF format via the MOH DMEC online portal.
📌 Vietnamese translations are required for IFU, labeling, and risk classification justification.

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